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510(k) K232788

INSPIRA ART100 by Inspira Technologies Oxy B.H.N. , Ltd. — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2024
Date Received
September 11, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

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